Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia

Официальное название

The Evaluation of the Effects of Computer-controlled Electronic Anesthesia Systems and Traditional Local Anesthesia Techniques, Along With Different Anesthetic Agents, on Pain and Anxiety Levels During Dental Treatments in Pediatric Patients: A Randomized Controlled Clinical Study

Обзор

The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system. The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients? By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.

Подробное описание

This randomized controlled clinical trial will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. The study will include 84 voluntary pediatric patients aged between 7 and 10 years who meet the eligibility criteria defined.These patients will be selected among those who present with a clinical need for pulpotomy or pulpectomy proce dures in their primary molar teeth located in either the upper or lower jaws. Prior to any intervention, patients and their legal guardians will be fully informed about the study, and written informed consent will be obtained. The study aims to evaluate and compare the impact of traditional local anesthesia techniques and computer-controlled local anesthetic delivery systems (CCLAD) on children's pain and anxiety levels during dental procedures.

In a within-subject crossover design, both traditional (syringe-based) and computer-controlled anesthesia methods will be applied to the same patient but on different sides of the mouth. This design enables objective comparisons and minimizes inter-individual variability. A total of 42 patients will be included in each group, with each child serving as their own control. Local anesthesia will be administered to teeth requiring treatment either on the left or right side, depending on the clinical indication.

The primary and secondary outcome measures will include assessments of both physiological and psychological parameters. Pain and anxiety will be measured using a combination of psychometric, physiological, and biochemical evaluation methods. These include:

Physiological measurements: heart rate, oxygen saturation (SpO₂) and body temperature.

Psychometric scales:

Facial Image Scale (FIS) Visual Analog Scale (VAS) Wong-Baker Faces Pain Rating Scale (WBS) Modified Child Dental Anxiety Scale (MCDAS) Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) FLACC Behavioral Pain Scale (Face, Legs, Activity, Cry, Consolability) Data from these assessments will be recorded for both groups and analyzed to determine which anesthesia technique provides the best outcome in terms of minimizing pain and anxiety.

Although this is not a patient registry study, quality assurance measures will be applied to ensure data integrity. These include:

Regular validation checks for consistency and completeness during data entry. Source data verification against patient records and clinical forms. A standardized data dictionary defining all variables used, including their measurement units and coding schemes where applicable.

Implementation of standard operating procedures (SOPs) for participant enrollment, data collection, safety monitoring, and data management.

Statistical analyses will be planned according to a predefined protocol, using appropriate tests to evaluate differences between interventions.

A sample size calculation has been performed to ensure that 84 patients are sufficient to detect clinically significant differences.

A missing data management plan is in place to handle incomplete or inconsistent entries, ensuring statistical robustness and data quality.

This study is expected to contribute valuable evidence to the field of pediatric dentistry by identifying the most effective and child-friendly local anesthesia method, thereby improving patient care and treatment experiences.

Вмешательства

• Устройство Digital Anesthesia with SleeperOne 5
  For both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle.
• Устройство Infiltration Anesthesia with a Metal Cartridge Syringe
  For maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute.
• Устройство Mandibular Block Anesthesia with a Metal Cartridge Syringe
  For mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique.

Первичные конечные точки

• To assess the patient's pain level (Before and after anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• To assess the patient's pain level (During anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• To assess the patient's pain level (During anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• To assess the patient's anxiety level (Before anesthesia ) [Срок оценки: through study completion, an average of 6 month.]
• To assess the patient's anxiety level (Before and after anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• Pulse rate measurement to assess patient's dental anxiety (Before,after and during anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• Blood oxygen saturation measurement to assess patient's dental anxiety (Before,after and during anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• Body temperature measurement to assess the patient's anxiety (Before,after and during anesthesia) [Срок оценки: through study completion, an average of 6 month.]

Вторичные конечные точки (3)

• Pulse rate measurement to assess opetator's anxiety (Before,after and during anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• Body temperature measurement to assess the operator's anxiety (Before,after and during anesthesia) [Срок оценки: through study completion, an average of 6 month.]
• Blood oxygen saturation measurement to assess operator's anxiety (Before,after and during anesthesia) [Срок оценки: through study completion, an average of 6 month.]

Критерии участия

Критерии включения

• Patients classified as ASA I in general systemic health

• Children between 7 and 10 years of age
• Absence of any syndromic condition
• No physical or mental disability
• No prior dental treatment experience
• Frankl Behavior Rating Scale Class III or IV
• Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides
• Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides
• Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs

Критерии исключения

• Patients with mild or severe systemic diseases or those undergoing medical treatment

• Patients younger than 7 or older than 10 years of age
• Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale
• Patients requiring urgent dental treatment
• Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces
• Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw
• Teeth with carious lesions not reaching half of the dentin thickness on radiographic evaluation or lacking intact dentin at the pulp border
• Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Dicle University Faculty of Dentistry, Department of Pediatric Dentistry — Diyarbakır

Идентификаторы

NCT: NCT07156487 · HRÜ/25.06.54

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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